510(k) · Cleared
ClearedTelerehad 2004
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scottcare · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Apr 13, 2005 as substantially equivalent to K895719 (Scottcare Corp., 1990) and 1 other predicate after a 16-day review. Its family tree reaches back 2 generations to 2001. 2 later devices descend from it.
- Decided
- Apr 13, 2005
- Review
- 16 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K003576 (2001). 3 ancestors in all, the oldest K895719 (1990). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK003576 Q-Tel RMS (Rehabilitation Management System), Model 000503Quinton, Inc. · 2001 · Recalled
- 1 generation backK041607 Quinton Q-TE; RMSQuinton Cardiology, Inc. · 2004 · Recalled
- This deviceK050778 Telerehad 2004Scottcare · 2005
- Descendant · cites it directly · 1 of its ownK212883 ers2 - ergoline Rehabilitation SystemErgoline GmbH · 2022
- Descendant · 2 generations on · 0 of its ownK250259 TeleRehab Aermos Cardiopulmonary RehabilitationThe ScottCare Corporation · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003576 | Q-Tel RMS (Rehabilitation Management System), Model 000503 | Quinton, Inc. | 2001 | 1 |
| −1 | K041607 | Quinton Q-TE; RMS | Quinton Cardiology, Inc. | 2004 | 1 |
| 0 (this device) | K050778 | Telerehad 2004 | Scottcare | 2005 | — |
| +1 | K212883 | ers2 - ergoline Rehabilitation System | Ergoline GmbH | 2022 | — |
| +2 | K250259 | TeleRehab Aermos Cardiopulmonary Rehabilitation | The ScottCare Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DRG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DRG device
- #1 K223711 ANNE Onescore 20.8 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K895719 | Telerehab System for Cardiac RehabilitationSummary page 1…for Cardiac Rehabilitation." ScottCare Corporation's "ScottCare TeleRehabTM System System." (K041607) (K895719) and Quinton "Q-Tel Rehabilitation Management Intended Use:… | 1990 |
| * | K041607 | Quinton Q-TE; RMSSummary page 1…for Cardiac Rehabilitation." ScottCare Corporation's "ScottCare TeleRehabTM System System." (K041607) (K895719) and Quinton "Q-Tel Rehabilitation Management Intended Use:… | 2004 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212883 | ers2 - ergoline Rehabilitation System | 2022 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K212883 (Ergoline GmbH, 2022) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DRG devicesDRG Transmitters And Receivers, Physiological Signal, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRG
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRG
3in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRG
52in 2025
MAUDE reports naming product code DRG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 63 | 3 | 14 |
| 2008 | 5 | 74 | 0 | 9 |
| 2009 | 13 | 94 | 0 | 5 |
| 2010 | 10 | 68 | 0 | 13 |
| 2011 | 9 | 104 | 0 | 12 |
| 2012 | 12 | 103 | 0 | 9 |
| 2013 | 13 | 146 | 0 | 13 |
| 2014 | 10 | 177 | 0 | 97 |
| 2015 | 2 | — | 0 | 131 |
| 2016 | 2 | — | 0 | 182 |
| 2017 | 7 | 98 | 0 | 484 |
| 2018 | 6 | 220 | 0 | 166 |
| 2019 | 5 | 122 | 0 | 70 |
| 2020 | 6 | 159 | 0 | 82 |
| 2021 | 2 | — | 0 | 107 |
| 2022 | 6 | 287 | 0 | 43 |
| 2023 | 4 | 212 | 0 | 19 |
| 2024 | 3 | 125 | 0 | 26 |
| 2025 | 3 | 127 | 0 | 52 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
This device is intended to acquire and condition the ECG signal from a patient so that it can be transmitted via radio frequency (WMTF) with a Stickman telemetry transmitter to a workstation in a hospital or clinical setting where the ECG is displayed and analyzed. This device is for use with ambulatory adult patients, which need monitoring while undergoing cardiac or pulmonary rehabilitation. The data output from monitoring is viewed and stored on a…
Read the full statement (124 words)
This device is intended to acquire and condition the ECG signal from a patient so that it can be transmitted via radio frequency (WMTF) with a Stickman telemetry transmitter to a workstation in a hospital or clinical setting where the ECG is displayed and analyzed. This device is for use with ambulatory adult patients, which need monitoring while undergoing cardiac or pulmonary rehabilitation. The data output from monitoring is viewed and stored on a workstation for tracking of the patients' progress through rehabilitation or other monitoring. Patient demographics, exercise protocol and medical information can be entered via a variety of commercially available wireless input devices or automatically through an HL-7 hospital network interface. A database can be created for use with an Outcomes program.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050778 · printed Nov 3, 2026
Cite this page
510(k) Report. “K050778: Telerehad 2004.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050778
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026